An Eight-week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Generalized Anxiety Disorder

Phase 2 Completed 325 enrolled Sanofi

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and paroxetine 20 mg once daily in outpatients with generalized anxiety disorder

Timeline

Start: 2006-08
Primary completion: 2008-02
Completion: 2008-02

Outcome

Missed primary endpoint

paper In the GAD trial, SSR149415 did not separate from placebo on the primary (HARS-100 mg: P = .29; 250 mg: P = .21) PMID 23146246 ↗

Publications

Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NELIVAPTAN	Small molecule	100 mg	Oral
Subject	NELIVAPTAN	Small molecule	250 mg	Oral
Comparator	Paroxetine	Small molecule	20 mg	Oral